Prescription Drug Found in Dietary Supplements

Products advertising red yeast rice products have been on the web for a long time. Along with diet and exercise, the manufacturer’s claim these products will help to reduce one’s cholesterol. Purportedly, this product has been used in Asia for almost 3000 years (and we all know Asians are petite and thin and healthy, right?).

The manufacturer’s are commended for placing warning labels on all of their products which state:

• Do not use this product if you are pregnant; can become pregnant; if you are under age 20; have liver disease; consume more than two alcoholic drinks per day; are allergic to soy or rice; have had major surgery or organ transplant surgery within the past six weeks.
• Discontinue use immediately if muscle pain and tenderness or flu-like symptoms occur.
• If you are taking prescription medications, consult a physician before taking this product.

However, The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health.

The potentially harmful products are:

• Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc.
• Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Kabco Inc.,
• Cholestrix, sold by Sunburst Biorganics.

FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol. None of the bottles listed lovastatin as an ingredient in their pills.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act.